- Insmed Incorporated (San Diego, CA)
- …11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing ... Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS,… more
- Syner-G BioPharma Group (Boston, MA)
- …the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in ... information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Cipla (Hauppauge, NY)
- …orders, protocols, reports. Perform gap assessments and remediation as required on legacy validation packages. Interface with the FDA and customers during site ... Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location :...pharmacy) or a related field. Must be proficient in computer skills and software applications such as Microsoft Office… more
- ValSource, Inc. (Rahway, NJ)
- …regulated projects. Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering ... Regulatory Compliance: Ensure compliance with all relevant regulatory standards, including FDA , GMP, and ICH guidelines, during on-site validation . Prepare… more
- Insmed Incorporated (NJ)
- …Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing ... process) Who You Are:5+ years' experience in a management validation role with responsibility for computer systems...a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- AUROBINDO (Durham, NC)
- …GxP systems.Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer ... company policies. This role involves planning, executing, and documenting validation activities for IT systems, laboratory instruments, and manufacturing… more
- Insmed Incorporated (NJ)
- …with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of ... Who You Are:3+ years' hands on experience in a validation role with responsibility for computer systems...processes is preferred.Solid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:Lead the cross-functional Device Working Groups… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Cipla (Fall River, MA)
- …controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management ... approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents,… more
- Cipla (Central Islip, NY)
- …Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports. Conduct focused time-studies to support packaging ... investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required. Apply complete knowledge of process improvement… more
- Twist BioScience (South San Francisco, CA)
- …teams.Work with test engineers to develop and execute verification and validation protocols to ensure software reliability and compliance.Support automated and ... and user manuals.Ensure software complies with applicable regulatory standards (eg, FDA , ISO 13485, if applicable).Contribute to research and development efforts for… more
- Cardinal Health (Augusta, ME)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance with ... strategic guidance, technical expertise, and hands-on support throughout the validation lifecycle, including planning, execution, documentation, and audit readiness.… more
- Zimmer Biomet (Austin, TX)
- …regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity + You have experience with ... this role you will provide leadership and technical direction in software validation , verification, regression testing, and cybersecurity to ensure compliance with … more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- Medtronic (Juncos, PR)
- …automated systems, vision inspection systems, robotics, and digital factory technologies. + Ensure validation packages comply with FDA 21 CFR Part 11, ISO 13485, ... documentation (URS, FAT/SAT, IQ/OQ/PQ, TMV, risk assessments). + Understanding of Computer System Validation (CSV) principles for integrated control and… more
